IEC 60601-2-45 Mammographic X-Ray Equipment and Mammographic Stereotactic Devices Testing
Medical electrical equipment – Part 2-45: basic safety and essential performance of mammographic X-ray equipment and mammomagraphic stereotactic devices
IEC 60601-2-45 Scope:
IEC 60601 2 45 and EN 60601 2 45 testing applies to the basic safety and essential performance of mammographic X-ray equipment, including equipment for mammographic tomosynthesis, and mammographic stereotactic devices, hereafter also referred to as medical electronic equipment.
NOTE 1 This includes mammographic X-ray equipment using integrated digital X-ray image receptors or integrated storage phosphor subsystems.
Excluded from the scope of IEC 60601 2 45 are:
- Reconstructive tomography modes of operation other than mammographic tomosynthesis;
- CT scanners covered by IEC 60601-2-44;
- Diagnostic consoles;
- Picture archiving and communication systems (PACS);
- Non-integrated storage phosphor readers;
- Hard copy cameras;
- Films, screens and cassettes;
- Computer aided detection (CAD);
- Devices for performing core biopsy and other biopsy instruments;
- Modes of operation intended to demonstrate local contrast medium uptake (contrast enhanced digital mammography);
NOTE 2 IEC 60601-2-7:1998 and IEC 60601-2-32 are not part of the 3rd edition scheme for mammographic X-ray equipment and mammographic stereotactic devices.
Keystone Compliance assists manufacturers with IEC 60601-2-45 and EN 60601-2-45 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-45 test lab needs.